Clinical Research Directory

Education and Health in Women With Cervical Cancer

Introduction: Cervical neoplasms constitute a significant public health problem on a global scale. According to the National Cancer Institute, this pathology is the third most prevalent type of cancer among women in Brazil, and the second most incident neoplasm in the North and Northeast regions. Estimates for each year of the 2023-2025 triennium point to approximately 17,010 new cases, with a gross incidence rate of 15.38 cases per 100,000 women. Health education emerges as a fundamental strategy in promoting healthy behaviors and building critical awareness of the health-disease process, considering individual and collective particularities. Objective: To evaluate the effect of health education on the level of quality of life, physical activity, self-esteem, anxiety, depression, nutrition, and pain in women with cervical cancer. Materials and Methods: This is a clinical trial with cervical cancer patients. The sample will be randomly distributed into two groups: the Health Education Recommendations Group (HERG) and the Control Group (CG), which will remain under usual care. The intervention will last 12 weeks, during which the HERG will receive health education recommendations through face-to-face meetings and via social media. The variables in this study are the participants' sociodemographic and clinical profile, lifestyle, sedentary behavior, level of physical activity, nutrition, self-esteem, anxiety and depression, quality of life, and pain. The variables of interest will be evaluated at baseline, after 6 and 12 weeks through multivariate analysis, comparing the effects of group, time, and interaction of both. Analyses will be performed using SPSS version 24.0 software, with a significance level of 5%. Expected results: Lifestyle change in at least two addressed areas. The developed material contributes to the scientific literature through the creation of textbooks, articles, and by offering valuable insights into the effectiveness of health education strategies. Future research can expand this work, adapting it to other populations or contexts to maximize its impact.

Kupewa: Optimizing Implementation Strategies for Cervical Cancer Prevention

The goal of this clinical trial is identify an effective and implementable set of implementation strategies to increase cervical cancer prevention in Malawi. The main questions it aims to answer are: 1. Which implementation strategies produce the greatest increase in provider recommendation for, and uptake of, cervical cancer prevention tools among people receiving HIV care. 2. What is the acceptability, appropriateness, feasibility, and cost of these implementation strategies. 3. What is the sustained effect of these implementation strategies. The implementation strategies will be conducted with health workers (clinical officers, nurses, and medical assistants): training, coaching, and a reminder system.

A Trial to Establish Non-inferiority of Immunogenicity of a Single-dose of CERVAVAC® Quadrivalent HPV Vaccine Compared to the Gardasil® Quadrivalent Vaccine Among Girls and Boys Aged 9 to 14 Years and in Girls/Women Aged 15 to 20 Years in Zambia

The goal of this study is to compare the immune response of the single dose of the CERVAVAC vaccine with the single dose of Gardasil vaccine in girls/women aged 9 to 20 and boys aged 9 to 14 at 6 months, 12 months and 24 months post vaccination. The vaccine will be given randomly to the boys and girls/women in these age group and they will be followed up to check the immune status developed in them after vaccination. The status of immune response developed by the two differnet vaccines will be compared in these group of participants of the study.

A Cervical Cancer Prevention Program in Kenya

Cervical cancer is caused by oncogenic, or "high-risk" (HR) human papillomavirus (HPV), and is the main cause of cancer-related death among Kenyan women. This malignancy is theoretically preventable through a combination of screening of adult women and treating those with cervical premalignancies and vaccination of children and adolescents against HPV infection. However, only 5% of Kenyan women are regularly screened, and only 14% have ever been screened, which in Kenya is done by a method known as Visual Inspection with Acetic Acid (VIA). Possible obstacles to current screening include long travel to clinics, high costs, poor sensitivity and specificity of VIA, the need for extensive training for VIA, variability among providers in their interpretation of VIA, lack of trained personnel, and others. In addition, while safe and effective HPV vaccines have been available for 15 years, very few (\<1%) Kenyan children and adolescents have been vaccinated. Obstacles to vaccination include high costs, poor delivery infrastructure, lack of education, long travel to clinics, and others. The investigators began a community-based program in 2018 to develop a framework for eradication of cervical cancer by screening adult women and vaccinating female children. This program is becoming accepted in the Webuye region of Western Kenya, but there is still a great deal to learn. Going forward, this initiative will be known as the Kenya Mother-Daughter Cervical Cancer Eradication Program, or the Mother-Daughter Program (MDP) for short. The investigators propose a continuation of the MDP that will allow them to accumulate additional data needed to solidify the overall project and to answer additional questions as described below. To accomplish this goal the investigators will first enroll an additional 300 adult women to the program. This will increase the strength of the analysis of HR-HPV testing in detecting premalignant lesions of the cervix, especially in HIV-infected women. Second, the investigators will identify the positive and negative features of the MDP from the viewpoint of both the adult women and the girls enrolled in the program. Third, because anogenital warts (AGWs) may serve as a reservoir for HR-HPV, especially in women living with HIV/AIDS, the investigators will examine the prevalence, HPV type distribution, and treatment of these lesions among adult women participating in the MDP.

Two Domestic HPV Vaccines and Imported HPV Vaccines in Women Aged 13-14 Years Study on Immunogenicity

This is a multi-center, open, prospective cohort study that aims to investigate the immunogenicity and immune persistence of two different domestically produced bivalent HPV vaccines compared with an imported HPV vaccine in women aged 13-14 years. A total of 3,000 subjects who have completed 2 doses of the domestic bivalent HPV vaccine and 3 doses of the imported HPV vaccine will be recruited from Fujian Maternal and Child Health Hospital as the initiator of the study, and will be recruited from a number of healthcare institutions nationwide. Of these, 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Wozehui), 1,000 subjects were vaccinated with the domestic bivalent HPV vaccine (Cecolin), and 1,000 subjects were vaccinated with the imported HPV vaccine. Each subject was enrolled within 30-60 days after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine, and a total of two follow-up visits were conducted 12 months (window period ± 1 month) and 36 months (window period ± 1 month) after the last dose of domestic bivalent HPV vaccine or imported HPV vaccine. In response to the WHO Cervical Cancer Elimination Strategy, domestic bivalent HPV vaccine has been offered free of charge to adolescent females aged 13-14 years, but there is still a lack of evidence comparing the antibody titer levels of domestic HPV vaccine and imported HPV vaccine in younger females. Therefore, we conducted the present immunogenicity study to explore the immunogenicity and immune persistence after vaccination with domestic bivalent HPV vaccine versus imported HPV vaccine in this age group of females.